Drug · FAERS side-effect profile with label screen
Decitabine side effects: what 4,243 FDA adverse event reports show
Drug class
Nucleoside Metabolic Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
4,243 reports · 95% serious · 1,154 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anem.
FDA label, Indications and Usage
What it is
Decitabine is a nucleoside metabolic inhibitor. Decitabine is a white to off white coloured powder with the molecular formula of C 8 H 12 N 4 O 4 and a molecular weight of 228.21.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 14Labeled (related wording) 7Likely indication confounding 3Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 11
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 100 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acute myeloid leukaemia | 240 | 77.3 68.3–87.5ROR 81.9 · χ² 17,741 / p <1e-300 | 75.7 EB05 68.0 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 46.5 | no trial data cached |
| Myelosuppression | 372 | 54.6 49.5–60.2ROR 59.8 · χ² 19,342 / p <1e-300 | 53.9 EB05 49.4 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.8 · 97% clinician | no trial data cached |
| Febrile neutropenia | 455 | 34.2 31.3–37.3ROR 38.2 · χ² 14,565 / p <1e-300 | 33.9 EB05 31.4 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 · 92% clinician | no trial data cached |
| Myelodysplastic syndrome | 88 | 30.2 24.6–37.2ROR 30.8 · χ² 2,444 / p <1e-300 | 29.9 EB05 25.0 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 18.4 | no trial data cached |
| Haematotoxicity | 54 | 28.9 22.2–37.8ROR 29.3 · χ² 1,421 / p <1e-300 | 28.5 EB05 22.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · 100% clinician | no trial data cached |
| Cytopenia | 67 | 27.9 21.9–35.3ROR 28.3 · χ² 1,699 / p <1e-300 | 27.5 EB05 22.4 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 | no trial data cached |
| Bone marrow failure | 110 | 26.7 22.2–32.1ROR 27.4 · χ² 2,684 / p <1e-300 | 26.5 EB05 22.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · 95% clinician | no trial data cached |
| Bacteraemia | 62 | 26.2 20.4–33.5ROR 26.5 · χ² 1,468 / p <1e-300 | 25.8 EB05 20.9 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.9 · ♀ 21% (drug 42%) | no trial data cached |
| Therapy partial responder | 48 | 15.8 11.9–20.9ROR 16.0 · χ² 649 / p 2e-143 | 15.6 EB05 12.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 98% clinician | no trial data cached |
| Hyperbilirubinaemia | 31 | 14.9 10.5–21.2ROR 15.0 · χ² 387 / p 2e-86 | 14.6 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 97% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 154 | 13.7 11.7–16.0ROR 14.2 · χ² 1,798 / p <1e-300 | 13.6 EB05 11.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 91% clinician | no trial data cached |
| Mucosal inflammation | 72 | 13.7 10.9–17.2ROR 13.9 · χ² 833 / p 2e-183 | 13.5 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · 92% clinician | no trial data cached |
| Lung infection | 42 | 13.2 9.8–17.8ROR 13.3 · χ² 461 / p 2e-102 | 12.9 EB05 9.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 93% clinician | no trial data cached |
| Hospice care | 25 | 12.6 8.5–18.6ROR 12.6 · χ² 254 / p 2e-57 | 11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 24 | 12.5 8.4–18.6ROR 12.6 · χ² 242 / p 8e-55 | 11.8 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 100% (drug 42%) · 92% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 240 | 10.7 9.4–12.1ROR 11.2 · χ² 2,097 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 287 | 10.5 9.4–11.7ROR 11.2 · χ² 2,464 / p <1e-300 | 10.4 EB05 9.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 91% clinician | no trial data cached |
| Therapy non-responder | 92 | 10.2 8.3–12.5ROR 10.4 · χ² 756 / p 1e-166 | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · 100% clinician | no trial data cached |
| Septic shock | 86 | 9.8 8.0–12.1ROR 10.0 · χ² 675 / p 4e-149 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Clostridium difficile colitis | 21 | 9.8 6.4–15.0ROR 9.8 · χ² 157 / p 3e-36 | 8.8 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Sepsis (blood infection) | 206 | 9.1 8.0–10.4ROR 9.6 · χ² 1,489 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 94% clinician | no trial data cached |
| Haemorrhage intracranial | 26 | 8.6 5.8–12.6ROR 8.6 · χ² 166 / p 2e-38 | 7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 96% clinician | no trial data cached |
| Neutrophil count decreased | 66 | 8.1 6.3–10.2ROR 8.2 · χ² 401 / p 1e-89 | 7.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Respiratory failure | 117 | 7.9 6.6–9.5ROR 8.1 · χ² 703 / p 3e-155 | 7.7 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Disease progression | 189 | 7.9 6.9–9.1ROR 8.3 · χ² 1,142 / p 1e-250 | 7.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 91% clinician | no trial data cached |
| Bacterial infection | 29 | 7.7 5.4–11.1ROR 7.8 · χ² 163 / p 1e-37 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Skin infection | 17 | 7.5 4.7–12.1ROR 7.6 · χ² 90 / p 1e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | no trial data cached |
| Leukocytosis | 27 | 7.4 5.1–10.8ROR 7.4 · χ² 143 / p 3e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 93% clinician | no trial data cached |
| Leukaemia | 14 | 7.3 4.4–12.4ROR 7.4 · χ² 70 / p 2e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.5 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 27 | 7.2 5.0–10.5ROR 7.3 · χ² 139 / p 3e-32 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 · 96% clinician | no trial data cached |
| Platelet count decreased | 154 | 7.2 6.1–8.4ROR 7.4 · χ² 812 / p 7e-179 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Transfusion | 15 | 7.1 4.3–11.7ROR 7.1 · χ² 72 / p 1e-17 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Cardiomyopathy | 21 | 7.0 4.6–10.8ROR 7.1 · χ² 102 / p 2e-24 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 90% clinician | no trial data cached |
| Acute respiratory failure | 27 | 7.0 4.8–10.2ROR 7.0 · χ² 132 / p 7e-31 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 100% clinician | no trial data cached |
| Drug resistance | 36 | 6.9 5.0–9.6ROR 7.0 · χ² 177 / p 1e-40 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 100% clinician | no trial data cached |
| Blood count abnormal | 21 | 6.8 4.4–10.4ROR 6.8 · χ² 97 / p 3e-23 | 6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · 76% consumer | no trial data cached |
| Thrombotic microangiopathy | 13 | 6.6 3.9–11.4ROR 6.7 · χ² 57 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Gingival bleeding | 18 | 6.5 4.1–10.3ROR 6.5 · χ² 78 / p 4e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Infection | 178 | 6.1 5.3–7.1ROR 6.3 · χ² 759 / p 2e-167 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Multiple organ dysfunction syndrome | 34 | 6.0 4.3–8.4ROR 6.1 · χ² 138 / p 5e-32 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 501 | 2.9 2.6–3.1ROR 3.1 · χ² 627 / p 1e-138 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Febrile neutropenia | 455 | 34.2 31.3–37.3ROR 38.2 · χ² 14,565 / p <1e-300 | 33.9 EB05 31.4 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 · 92% clinician | no trial data cached |
| Myelosuppression | 372 | 54.6 49.5–60.2ROR 59.8 · χ² 19,342 / p <1e-300 | 53.9 EB05 49.4 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.8 · 97% clinician | no trial data cached |
| Pneumonia (lung infection) | 319 | 4.9 4.4–5.4ROR 5.2 · χ² 995 / p 1e-218 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 90% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 287 | 10.5 9.4–11.7ROR 11.2 · χ² 2,464 / p <1e-300 | 10.4 EB05 9.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 91% clinician | no trial data cached |
| Death | 285 | 1.6 1.5–1.8ROR 1.7 · χ² 73 / p 8e-18 | 1.6 EB05 1.5 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Pyrexia (fever) | 260 | 3.7 3.3–4.2ROR 3.9 · χ² 521 / p 1e-115 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Thrombocytopenia (low platelets) | 240 | 10.7 9.4–12.1ROR 11.2 · χ² 2,097 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 95% clinician | no trial data cached |
| Acute myeloid leukaemia | 240 | 77.3 68.3–87.5ROR 81.9 · χ² 17,741 / p <1e-300 | 75.7 EB05 68.0 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 46.5 | no trial data cached |
| Product use in unapproved indication | 218 | 4.4 3.9–5.0ROR 4.6 · χ² 578 / p 5e-128 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 206 | 9.1 8.0–10.4ROR 9.6 · χ² 1,489 / p <1e-300 | 9.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 94% clinician | no trial data cached |
| Disease progression | 189 | 7.9 6.9–9.1ROR 8.3 · χ² 1,142 / p 1e-250 | 7.8 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 91% clinician | no trial data cached |
| Infection | 178 | 6.1 5.3–7.1ROR 6.3 · χ² 759 / p 2e-167 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Anaemia (low red blood cells) | 167 | 4.3 3.7–5.0ROR 4.5 · χ² 427 / p 3e-95 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.8 · 91% clinician | no trial data cached |
| Platelet count decreased | 154 | 7.2 6.1–8.4ROR 7.4 · χ² 812 / p 7e-179 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haematotoxicity — n=54, PRR 28.9
- Bone marrow failure — n=110, PRR 26.7
- Hyperbilirubinaemia — n=31, PRR 14.9
- Hospice care — n=25, PRR 12.6
- Posterior reversible encephalopathy syndrome — n=24, PRR 12.5
- Septic shock — n=86, PRR 9.8
- Clostridium difficile colitis — n=21, PRR 9.8
- Bacterial infection — n=29, PRR 7.7
- Leukocytosis — n=27, PRR 7.4
- Multiple organ dysfunction syndrome — n=34, PRR 6.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Decitabine?
In FDA FAERS, the most frequently co-reported reaction terms for Decitabine are febrile neutropenia, myelosuppression, pneumonia, neutropenia, pyrexia, thrombocytopenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Decitabine have an FDA boxed warning?
No. The FDA label retrieved for Decitabine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Decitabine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 358764ca-4c69-d516-af0c-bf8a348d26ca, effective 20260325; matched on
openfda.generic_name.exact:"DECITABINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 140 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.